ClinicalTrials.gg
CompletedNCT03272204Updated Jun 4, 2020

Pubic Hair and the Urinary and Vaginal Microbiome

An interventional study of No pubic hair and Pubic Hair in Healthy, sponsored by Margaret Mueller. Completed at 1 site in United States. Open to female participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-06-04.

Sponsored by Margaret Mueller · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
43
Allocation
Non-randomized
Ages
18 Years to 50 Years
Sex
Female
01

Study summary

This research study seeks to find if there is a connection between the presence of pubic hair and the type of bacteria that live in the vagina and bladder.

Read the detailed description

Urinary tract infections (UTIs) are the most common bacterial infections. In 2007, in the United States alone, there were an estimated 10.5 million office visits for UTI symptoms (constituting 0.9% of all ambulatory visits) and 2-3 million emergency department visits. UTIs are significantly more common in women and are a leading cause of urogynecology referrals. In women, the vagina plays a key role in the pathogenesis of UTIs. The initial step in the pathogenesis of UTI is colonization of the vaginal opening and peri-urethra with uropathogens from the intestinal microbiota, followed by ascension of uropathogens via the urethra to the bladder and sometimes the kidneys to cause infection. Thus, understanding factors that affect the microbiota of the vagina is key to understanding the pathogenesis of UTI. Likewise, since Wolfe et al published the first evidence of a urinary microbiome in 2012, there has been growing interest in whether the content of this microbiome could correlate with symptoms of the lower urinary tract. The urinary microbiome has been shown to correlate with symptoms of urgency incontinence but to date, there is no data on whether the composition of the urinary microbiome is associated with any change in risk for UTIs. If the urinary microbiome could play a role in the acquisition of clinical infection, then the factors that affect the microbiome of the bladder would be important in preventing UTIs. One plausible and modifiable factor that may change the vaginal and urinary microbiome is the presence of pubic hair. Hair in other parts of the body (nose, ears, eyebrows) traps and stops the passage of pathogens into our mucous membranes. Additionally, the sebum produced by hair follicles is bacteriostatic. However, some form of pubic hair grooming is performed by the majority of pre-menopausal women (83%) and 62% of women between age 18-40 report having removed ALL of their pubic hair at one point in life. This is predominantly done by using non-electric razors (61%) but other women use lasers, waxing and depilatory creams. Fifty-nine percent of women who perform pubic hair removal report their primary reason is to improve hygiene. However, there is no data that this practice changes hygiene, with the exception of preventing pubic hair lice. On the contrary, pubic hair removal has been associated with skin injury leading to inoculation of bacteria and viruses. In a recent cross-sectional study of pubic hair and sexually transmitted infections, researchers found that frequent pubic hair grooming was correlated with a higher risk for sexually transmitted infections (STIs). This preliminary work raises the question of whether the presence of pubic hair affects the vaginal or urinary microbiome, thereby changing a woman's risk of infection in either organ. Furthermore, specific pelvic floor disorders (PFDs) including painful bladder syndrome and urgency urinary incontinence have been associated with specific microbiome profiles. Therefore, by falsely attempting to maintain pelvic health through grooming practices, women might inadvertently be exposing themselves to PFDs mediated by changes in their urinary or vaginal microbiomes. The aim of this study is to address this question through a pilot study of urinary and vaginal microbiomes in women with and without pubic hair AND in the same woman with and without pubic hair.

02

Conditions studied

  • Healthy

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Keywords

  • pubic hair; grooming; urinary tract symptoms; vaginitis
03

In context

Vaginitis

98 studies on the registry are indexed under Vaginitis; 12 are open to participants now.

This study's enrollment of 43 is below the median of 108 across 71 interventional studies indexed under Vaginitis.

Browse Vaginitis studies →

Lead sponsor

This is the only study on the registry with Margaret Mueller as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Eligibility criteria

Inclusion Criteria:

  • Pre-menopausal women between the ages of 18-50
  • English-speaking
  • Women with either natural growth/distribution of pubic hair or complete removal of pubic hair through a reversible process.
  • Women who do not feel they have urinary or vaginal health problems and are not seeking care for these issues
  • Women must be willing and able to complete study documentation and study procedures.

Exclusion Criteria: Women will be excluded for any of the following:

  • Hair has been removed through an irreversible process like laser or electrolysis
  • Patient feels they have bothersome urinary or pelvic floor conditions for which they are seeking care (for example: vaginal prolapse, frequent urinary incontinence, chronic pelvic pain, bladder pain)
  • Patient plans on having any type of surgery in the next 2 months (due to likely antibiotic use)
  • Patient has a history of a transplant and is on
  • Patient has cancer for which she is currently getting chemotherapy or radiation
  • Currently taking or has taken antibiotics in the last 7 days for any reason
  • Patient has symptoms of a urinary tract or vaginal infection or is found on exam or culture to have a urinary tract infection or vaginal infection
  • Patient is pregnant or breastfeeding
  • Patient has douched in the last 48 hours
  • Patient has had intercourse in the last 48 hours
  • Patient is currently menstruating
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
43 participants (actual)

Study arms

  • Other
    Natural Pubic Hair

    Participant with natural hair crosses over to removed pubic hair

    Behavioral: No pubic hair

  • Other
    Removed Pubic Hair

    Participant with no pubic hair crosses over to natural pubic hair

    Behavioral: Pubic Hair

Interventions

  • BehavioralNo pubic hair

    Natural pubic hair to fully removed pubic hair

  • BehavioralPubic Hair

    Removed pubic hair to natural pubic hair

06

What researchers measure

Primary outcomes

  1. Comparison of Urinary and Vaginal Microbiomes

    Describe and compare the urinary and vaginal microbiome in the same woman with natural pubic hair and with fully removed pubic hair

    Time frame: up to 3 months

Secondary outcomes

  1. Questionnaire Comparison

    To compare questionnaire results for standardized patient surveys in the same woman with and without pubic hair

    Time frame: up to 3 months

  2. Self-Reported Infections

    Comparing self-reported vaginal infections and urinary tract infections between women who have natural pubic hair and women who fully remove their pubic hair

    Time frame: up to 3 months

  3. Subtracting Microbiome Results

    To suggest whether the transurethral urinary microbiome can be determined by subtracting the vaginal microbiome from the voided urinary microbiome

    Time frame: up to 3 months

07

Study locations

1 site
  • Northwestern University
    Chicago, Illinois 60611, United States
08

References and documents

Publications

  • Geynisman-Tan J, Kenton K, Tavathia M, Yee A, Gilbert JA, Collins S, Lewicky-Gaupp C, Mueller M. Bare Versus Hair: Do Pubic Hair Grooming Preferences Dictate the Urogenital Microbiome? Female Pelvic Med Reconstr Surg. 2021 Sep 1;27(9):532-537. doi: 10.1097/SPV.0000000000000968. PubMed 33181518 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Oct 2017 to primary completion in Jun 2019, 20 months.

Of 22 interventional studies with no phase under Vaginitis, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 35. This study's 20 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 18, 2017
First posted
Sep 5, 2017
StartActual
Oct 1, 2017
Primary completionActual
Jun 14, 2019
CompletionActual
Jun 14, 2019
Last update
Jun 4, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 4, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03272204
Lead sponsor
Margaret Mueller
Responsible party
Margaret Mueller (Assistant Professor of Obstetrics and Gynecology, Urology, Northwestern University) — Sponsor-investigator
First posted
Sep 5, 2017
Start date
Oct 1, 2017
Primary completion
Jun 14, 2019
Completion
Jun 14, 2019
Last update
Jun 4, 2020

Study contacts

Margaret G Mueller, MD
principal investigator · Northwestern University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.

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